Research means a "systematic investigation," according to the United States Department of Health and Human Services regulations (see References). This includes research development, tests and evaluations intended or undertaken to develop or contribute to generalizable knowledge.
Examples of systematic investigations, as interpreted by the University of California at Irvine, include surveys, questionnaires, interviews, focus groups, analysis of blood specimens or existing data, evaluation of social or educational programs and medical chart reviews. The university does not treat biographies, oral histories, course evaluations that persons cannot generalize to individuals and quality assurance programs with other content that is not intended for use beyond the university community as systematic investigations.
Research involves a human subject where the human is alive and the researcher or investigator obtains information about the subject from "intervention or interaction with the individual" or "private identifiable information," according to the United States Department of Health and Human Services regulations. Intervention occurs where the investigator manipulates or controls a subject's environment or surroundings for research or employs physical procedures upon the subject.
Human subjects in drug research receive test articles or participate as a control. The Food and Drug Administration includes as test articles drugs, biological products or medical devices to be used by humans; human food or color additives and electronic products. Participants in a control group receive the standard drug or treatment so that the researchers can compare the effects of the experimental article with the standard. Both healthy persons and patients can come within the definition of human subjects.
Federal regulations include as private information or private identifiable information (see Section 3) behavior occurring such that an individual reasonably expects that there is no observation or recording of the behavior and information provided for a specific purpose and that is reasonably not expected to be public, such as medical records. Information is not private if the investigator cannot reasonably ascertain the research subject's identity or associate the subject with the research.